External male catheters generally take the form of an elastic penile sheath connected at its distal end to a drainage tube that, in use of the device, leads to a suitable collection receptacle. Such a catheter is typically held in place by a pad or coating of pressure sensitive adhesive as shown, for example, in U.S. Pat. Nos. 3,835,857, 3,863,638, and 4,178,851. One particularly effective sheath in widespread use is disclosed in U.S. Pat. No. 4,581,026. Such sheath has an inner sleeve that sealingly but non-adhesively engages the glans of a wearer's penis, the inner sleeve being held in position by a coating or pad of adhesive material in contact with the penile shaft behind the glans. Reference may also be had to U.S. Pat. No. 4,588,397 and British application No. 2,125,294A as further illustrations of the state of the art.
For certain types of incontinent patients, intermittent internal catherization is necessary to empty the bladder more completely and avoid complications that might develop from long-term retention of residual urine. For example, incontinent patients with spinal cord injuries frequently require such intermittent internal catherization. Such a procedure involves removing the external catheter to expose the urethral meatus and permit the insertion of an internal catheter for direct draining of the bladder. For a patient whose spinal injury is recent, such intermittent internal catherization may have to be performed as frequently as every three to four hours, but such intermittent internal catherization followed by replacement of an external catheter is believed preferable to leaving an internal catheter in place. Intermittent internal catherization nevertheless burdens the nursing staff, since the steps of removing an external catheter, introducing and removing an internal catheter, and replacing an external catheter are time consuming (therefore increasing the economic burden of the institution and, ultimately, the patient) and must be performed with care to reduce the possibilities of patient infection or injury. Even so, patient injury is possible because the frequent removal and replacement of adhesive-coated external catheters may irritate and even seriously harm sensitive skin surfaces. In efforts to avoid the problems caused by frequently removing and applying adhesively-coated external catheters, medical personnel in some institutions have instead wrapped straps or tape about the outsides of non-adhesive catheters to hold them in place, thereby confronting an even greater risk of strangulation and resulting vascular and tissue damage.
Accordingly, important aspects of this invention lie in recognizing this problem and in providing an external male catheter that permits intermittent internal catherization without the disadvantages described above. More specifically, the invention lies in providing an external catheter composed of two main sections--an elastic sheath section and a urine-receiving section--that are connected together when the device is in use but may be readily separated when internal catherization is required. Since the two sections are coupled together in close proximity to the urethral meatus, detachment of the urine-receiving section exposes the meatus for internal catheterization. Because only the urine-receiving section needs to be removed, the sheath section and its adhesive attachment to the penile shaft may remain undisturbed. Following internal catherization, the urine-receiving section (either the original component or a fresh replacement) may be reconnected to the sheath section to return the external catheter to an operative state.
Several forms of two-section external catheters are disclosed herein. In all constructions, the catheter includes at least two sections, one section taking the form of an elongated tubular sheath of thin, stretchable, elastic material dimensioned to be fitted upon and extend along the shaft of a patient's penis. Such a sheath section has proximal and distal ends with the latter terminating in a distal opening located in close proximity to the urethral meatus when the sheath section is worn by a patient. Adhesive means, preferably an internal coating of pressure sensitive adhesive, secures the sheath section to the penile shaft behind the glans. Ideally, the sheath section includes a non-adhesive portion that is stretched over the glans just behind the urethral meatus to protect the glans against injury that might otherwise be occasioned by prolonged contact with residual amounts of urine that are often retained within an external catheter.
Each embodiment also includes a tapered tubular receiving section having a proximal end portion with an enlarged opening and a distal portion adapted for connection to a drainage tube. Connecting means releasably join the proximal end portion of the receiving section to the sheath section to permit selective detachment of the receiving section when access to the urethral meatus is required for internal catherization. In one embodiment the receiving section is formed of flexible but still fairly stiff (i.e., semi-rigid) plastic material and the distal end of the sheath section is clamped between the receiving section and an external cup-shaped clamping member. In another form the receiving section is again composed of relatively rigid plastic but the clamping member comprises a removable pressure-sensitive adhesive strip that performs the dual functions of holding the proximal end of the sheath section in fluid-tight contact with the receiving section and adhesively connecting the two sections together. A further embodiment utilizes a pair of coupling rings, and other forms involve no rigid clamping or coupling elements but rely entirely on an adhesive connection between the two sections.